Cresemba

Quick links to important sections

Cresemba

Treatment option: Aspergillosis,Aspergilloma

Medically reviewed

Marina Burgos

Last updated on 10/01/2026

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of Cresemba

What is Cresemba? (Overview)

Property Description
Active ingredient Isavuconazole (administered as the prodrug, Isavuconazonium sulfate)
Form Oral capsules and Lyophilized powder for intravenous (IV) solution
Pharmacological class Triazole Antifungal Agent
Common use Treatment of serious, systemic fungal infections (systemic mycoses)
Origin Synthetic
Manufacturer (US) Astellas Pharma US

What is Cresemba and Its Pharmacological Identity?

Cresemba is the trade name for a synthetic, prescription-only medication. Its active component is the systemic antifungal agent Isavuconazole. The drug belongs to the azole antifungal family and is specifically classified as a next-generation triazole antifungal agent. This class of medication is utilized to treat serious infections caused by various fungi that have spread throughout the body, a condition referred to as systemic mycoses. Isavuconazole possesses broad-spectrum activity against yeasts and certain aggressive molds, including Aspergillus species, providing a treatment option for patients who are immunocompromised.

Composition and Delivery: Unique Features of Isavuconazonium Sulfate

The medication contains the active substance Isavuconazole, which is administered as the compound Isavuconazonium sulfate. This compound is a prodrug designed for high water solubility. A primary pharmaceutical characteristic of this prodrug is that it allows for the preparation of an intravenous (IV) solution without the use of the solubilizing agent beta-cyclodextrin, which is required for some other azole antifungals. This formulation is used in the treatment of critically ill patients, including those with specific kidney considerations. The medication is available as oral capsules and a lyophilized powder for IV solution, allowing for the continuation of treatment across different clinical settings.

Regulatory References

  1. NIH

What side effects are possible with Cresemba?

Possible Side Effects and Safety Information for Cresemba (Isavuconazonium Sulfate)

Cresemba's safety profile is based on clinical data and post-marketing surveillance, with adverse reactions documented by frequency and system-organ class.

Adverse Reaction Frequencies (Most Common)

The following are classified based on the standard frequency framework used in regulatory documents:

Classification Examples of Adverse Reactions (by System-Organ Class)
Very Common (ge 1/10) Nausea, vomiting, diarrhea, headache, elevated liver chemistry tests, hypokalemia, constipation, dyspnea (shortness of breath).
Common (ge 1/100 to < 1/10) Abdominal pain, peripheral edema, back pain, rash, insomnia, somnolence, dyspepsia, delirium.
Uncommon (ge 1/1,000 to < 1/100) Convulsion, syncope, dizziness, neutropenia, thrombocytopenia, hepatitis, hypersensitivity.

Serious and Clinically Significant Adverse Reactions

Serious Hepatic Reactions including hepatitis and elevated liver transaminases (liver chemistry tests) have been reported, necessitating monitoring of hepatic enzymes. Severe Cutaneous Adverse Reactions (SCARs), such as Stevens-Johnson syndrome, have been reported with azole antifungals, and Cresemba should be discontinued if a SCAR is suspected. Infusion-related reactions including hypotension, dyspnea, and dizziness may occur during intravenous administration, requiring the infusion to be stopped if they arise.

Contraindications and Safety Restrictions

Cresemba is contraindicated in patients with a history of familial short QT syndrome, as the drug is known to shorten the QTc interval in a concentration-related manner. It is also contraindicated with co-administration of the strong CYP3A4 inhibitor ketoconazole, and strong to moderate CYP3A4/5 inducers such as rifampicin, carbamazepine, and phenytoin, due to the risk of significant changes in isavuconazole plasma concentrations. Use is not recommended in patients with severe hepatic impairment (Child-Pugh Class C) unless the benefit clearly outweighs the risks, with careful monitoring required. Women of childbearing potential are advised to use effective contraception during treatment and for 28 days following the last dose due to the potential risk of fetal harm.

Overdose and Emergency Response

The official regulatory profile for Cresemba (isavuconazonium sulfate) overdose is based on observations from clinical studies that utilized exposures significantly higher than the recommended maintenance dose. Overdose manifestations documented in official labeling primarily affect the nervous and gastrointestinal systems. These documented signs and symptoms may include headache, dizziness, nausea, vomiting, and diarrhea. Additionally, paresthesia (tingling or burning sensations) and hot flushes (sudden reddening of the face or chest) have been reported in the context of high-dose exposure.

The regulatory guidance on emergency action is clear that any suspected overdose requires immediately seeking medical attention. Life-threatening symptoms—specifically seizure, collapse (loss of consciousness), or trouble breathing (respiratory distress)—are considered urgent medical emergencies. In these severe scenarios, the official guidance mandates contacting emergency services immediately.

Management of an overdose is defined by the official labeling as symptomatic and supportive, meaning treatment addresses the specific clinical manifestations as they occur. It is explicitly stated in the regulatory documentation that no specific pharmacological antidote for isavuconazole is known. Furthermore, it is not established whether the active substance can be removed from the body through hemodialysis.

Therapeutic Uses of Cresemba

Cresemba is a dedicated, prescription antifungal treatment that is commonly used to manage serious, systemic fungal infections in patients who are often immunocompromised. Its therapeutic role involves managing fungal disease and supporting the patient by easing distress associated with systemic imbalance.

It is applied in addressing two critical fungal conditions: Invasive Aspergillosis (IA) and Invasive Mucormycosis (IM). These are conditions marked by increased physiological stress where the mold actively affects deep tissues.

Key Therapeutic Focus

This medication is applied in addressing the infection, which helps ease the symptoms related to systemic imbalance and groups of symptoms that may become intense or disruptive, such as persistent high fever and symptoms that create noticeable physiological strain. It is generally used in clinical settings that involve acute or unstable symptom patterns in highly vulnerable patients, including those with hematologic malignancies or recipients of stem cell transplants.

The medication is considered relevant in contexts involving heightened systemic burden, especially when the patient requires additional symptomatic support. This provides supportive relief that helps ease the overall symptom burden for patients and may assist with maintaining functional stability during symptomatic periods.


Quick Fact: Relief for Systemic Sickness

Cresemba is used for managing severe infections that cause symptoms related to systemic imbalance, helping patients cope more steadily with difficult manifestations like persistent fever and deep tissue strain.

Regulatory References

  1. European Medicines Agency (EMA) overview

Eligibility and Restrictions for Use

Eligibility Scope and Restrictions

Cresemba (isavuconazonium sulfate) is approved for use in adults (18 years and older) for the treatment of invasive aspergillosis and invasive mucormycosis.

Eligibility is defined by specific age groups and contraindications from regulatory labeling:

  • Pediatric Use: The intravenous injection is approved for patients 1 year of age and older. The oral capsules are approved for patients 6 years of age and older who weigh at least 16 kg. Use is not established in children under 1 year of age.
  • Renal and Hepatic Function: Use is allowed in patients with renal impairment or mild to moderate hepatic impairment; no dose adjustment is necessary. Use is not recommended in patients with severe hepatic impairment (Child-Pugh Class C) due to limited study data.

Contraindicated Populations

Cresemba is contraindicated (must not be used) in patients with the following conditions, as stated by regulatory authorities:

  • Known hypersensitivity to isavuconazonium sulfate or isavuconazole.
  • Known or suspected Familial Short QT Syndrome.
  • Concomitant use with strong CYP3A4 inducers (e.g., rifampin, carbamazepine, St. John's wort) or strong CYP3A4 inhibitors (e.g., ketoconazole, high-dose ritonavir).

Pregnancy and Lactation: Use is not recommended during pregnancy unless the potential benefit outweighs the risk in severe, life-threatening infections, and effective contraception must be used by women of reproductive potential. Breastfeeding should be discontinued during treatment.

What should I know about interactions with other medicines?

Cresemba (isavuconazonium sulfate) has an official interaction profile defined by its involvement with liver enzymes and transport proteins. The active moiety, isavuconazole, is a sensitive substrate of CYP3A4/5 and acts as a moderate inhibitor of CYP3A4/5 and a mild inhibitor of the P-glycoprotein (P-gp) transporter.

Contraindicated Combinations

Co-administration is forbidden with medicinal products that may significantly alter isavuconazole exposure or increase the risk of adverse effects. This includes:

  • Strong CYP3A4/5 Inhibitors such as ketoconazole, which markedly increase Cresemba levels.
  • Strong CYP3A4/5 Inducers (e.g., rifampin, carbamazepine, phenytoin, St. John's wort) and Moderate CYP3A4/5 Inducers (e.g., efavirenz, etravirine), which significantly decrease Cresemba exposure, potentially leading to loss of effectiveness.
  • High-dose ritonavir (doses above 200 mg every 12 hours).

Clinically Significant Interactions

Concomitant use with other drug classes requires specific clinical action due to Cresemba's ability to increase their concentration:

  • Immunosuppressants (e.g., cyclosporine, tacrolimus, sirolimus): These CYP3A4 substrates may have increased systemic exposure, necessitating therapeutic drug monitoring and dose adjustment.
  • Narrow Therapeutic Index P-gp Substrates (e.g., digoxin, colchicine, dabigatran etexilate): Increased exposure to these agents is possible, requiring careful monitoring for toxicity and potential dose modification.
  • Cresemba is also noted to be an inducer of CYP2B6, which may decrease the exposure of certain CYP2B6 substrates, warranting caution, especially for narrow therapeutic index agents like cyclophosphamide.

These constraints are formalized in regulatory documents to manage the risk of either reduced Cresemba effectiveness or increased toxicity of co-administered medicines.

Mechanism of Action

Prodrug Activation and Target Inhibition

The administered compound, isavuconazonium sulfate, is a prodrug that undergoes rapid enzymatic cleavage by plasma esterases to release the active antifungal moiety, isavuconazole. This active molecule interacts with and inhibits the fungal enzyme lanosterol 14-alpha-demethylase (CYP51). This mechanism provides a differential targeting action because the corresponding human enzyme is less sensitive to inhibition.

Pathway Disruption and Cell Structure Failure

Inhibition of CYP51 blocks a critical step in the ergosterol biosynthesis pathway. This prevents the conversion of lanosterol into ergosterol, a sterol essential for the structural integrity and function of the fungal cell membrane. The enzyme blockade leads to two intracellular consequences: ergosterol depletion and the accumulation of toxic intermediate sterols within the fungal cell. This cascade structurally destabilizes the membrane and increases its permeability, resulting in a disruption of fungal cell viability, exhibiting either fungistatic or fungicidal activity.

Dosage and Administration Information

Cresemba therapy is structured around a bimodal schedule, which initiates drug levels quickly before transitioning to a daily regimen. The medication is available for administration via two primary routes: intravenous (IV) infusion or through oral capsules, allowing for therapeutic flexibility between care settings.

The dosing schedule begins with a high-intensity loading phase. The standard adult dose, equivalent to 200 mg of isavuconazole, is administered every eight hours (q8h) for a total of six doses, completing the initial 48 hours of treatment. This is immediately followed by the maintenance phase, where the same 200 mg dose is administered once daily (qDay). Patients may transition between the IV and oral formulations without requiring an additional loading dose.

Regarding specific administration conditions, the oral capsules may be taken with or without food but must be swallowed whole, as they are not designed to be crushed, chewed, or opened. For the IV formulation, the solution must be administered via infusion over a minimum duration of one hour and requires the use of an in-line filter to ensure proper delivery.

Dosing is generally consistent across specified patient groups; adjustment is not required for adult patients with renal impairment or those with mild to moderate hepatic impairment. Pediatric dosing follows a weight-based regimen. If a maintenance dose is missed, guidance suggests the schedule should be resumed the following day at the regularly scheduled time.

Recent Clinical Evidence

Research Evidence Overview of Studies for Cresemba

The research landscape for Cresemba (isavuconazole) is primarily defined by two pivotal clinical trials that was studied for its use in specific, serious fungal infections. These studies, conducted across various countries, studies monitored the drug's activity over defined time intervals and studies contribute to the broader evidence landscape. Findings describe group patterns, not personal outcomes, and research provides context but not individual predictions.


Evidence for Use in Invasive Aspergillosis

Research into Invasive Aspergillosis (IA) involved a large-scale randomized, controlled trial. The research was studied for adults who were often highly vulnerable, including those with underlying blood cancers (hematologic malignancies) or who were recipients of stem cell transplants.

The primary study research examined the observed patterns in the isavuconazole group against an active comparator. Studies were designed to test whether the measurements of all-cause mortality in the two groups were comparable. Research describes measurements of certain organ-related research events, reporting different patterns of occurrence between the two groups observed.

The core evidence is limited by the trial design, which focused on establishing that the observed measurements in the isavuconazole group were similar to the observed measurements in the comparator group (non-inferiority), rather than exploring a specific advantage. Furthermore, results apply only to the populations studied, and data for certain high-risk subgroups remain insufficient, which means that individual outcomes can appear to vary.


Evidence for Use in Invasive Mucormycosis

For Invasive Mucormycosis (IM), the core evidence is from a Phase 3, non-comparative study without a randomized control group (the VITAL study) focusing specifically on this rare condition. The research examined adults who was studied for this condition, including those who had received the drug as salvage therapy.

Research examined measurements of all-cause mortality and overall treatment response in the patient group observed. Since there was no direct comparison group, the findings was compared against external historical data, which provided context for the observed patterns. This research provides insight into short-term changes.


Research Gaps and Remaining Uncertainties

The research base has specific limitations. The evidence level varies across studies, with the evidence level for IA being classified as High and the evidence level for IM being classified as Moderate. This difference stems from the non-comparative design used for the rare IM condition. Comparative evidence is lacking across all potential antifungal options, and long-term effects are not fully established from the initial research.

Frequently Asked Questions (FAQ)

Common questions about Cresemba (FAQ)

Q: Can Cresemba be taken with vitamins or herbal supplements?

A: Official documents state that Cresemba should not be used with strong CYP3A4/5 inducers. This group includes the herbal supplement St. John’s wort, which is strictly forbidden. Regulatory information indicates the importance of discussing all supplements with a healthcare provider, as potential drug interactions, including with strong enzyme inducers, must be managed.


Q: Is Cresemba safe for older patients?

A: Cresemba is approved for use in adults, and official regulatory information indicates that the dose is generally consistent across adult patient groups. No specific dose adjustment based solely on age is noted in the official guidance for the general elderly population. Dosing for adult patients, including older individuals, is determined by a healthcare professional based on the specific infection and patient characteristics.


Q: How is Cresemba different from other antifungal medications?

A: Cresemba is classified as a next-generation triazole antifungal. A key formulation difference is that its intravenous preparation does not require the use of cyclodextrin, which can be important for patients with reduced kidney function. Clinical studies have also shown its effect for invasive aspergillosis to be comparable to other antifungals like voriconazole.


Q: Are there any specific foods I should avoid while on Cresemba?

A: Official guidance states that the oral capsules may be taken with or without food. There are no specific foods listed in the product information that patients are required to avoid while taking this medication.


Q: What are the signs of a serious allergic reaction to Cresemba?

A: Official documentation notes that serious hypersensitivity reactions are possible, which may include symptoms such as low blood pressure, severe rash, or difficulty breathing. Official guidance states that infusion-related reactions may require the healthcare professional to stop the infusion if symptoms arise during administration.


Q: Does Cresemba affect blood pressure?

A: Low blood pressure, also known as hypotension, has been reported as an infusion-related reaction during the intravenous administration of Cresemba. Due to the potential for hypotension, monitoring of vital signs may be part of the care plan during intravenous administration.


Q: What official warnings are associated with Cresemba?

A: Official warnings include the potential for serious hepatic (liver) reactions and severe cutaneous adverse reactions (SCARs), such as Stevens-Johnson syndrome. Monitoring of liver function tests is described in the regulatory information as a necessary measure due to the potential for hepatic reactions.


Q: Can patients with a history of heart problems use Cresemba?

A: Cresemba is contraindicated (must not be used) in patients with known Familial Short QT Syndrome because the drug is known to shorten the QTc interval. It is important that patients disclose any history of abnormal heart rate or rhythm to their prescribing doctor, as this information is crucial for safety screening against the specified contraindication.


Q: Is Cresemba used to prevent infections?

A: The official approved indication for Cresemba is the treatment of invasive aspergillosis and invasive mucormycosis. While its primary use is treatment, official studies have also examined its use in patients deemed likely to benefit from prophylaxis (prevention) intervention.


Q: How does Cresemba compare to voriconazole in terms of general use?

A: In clinical studies examining invasive aspergillosis, the observed measurements of all-cause mortality for Cresemba were found to be comparable to those observed for voriconazole. Regulatory reviews also noted that Cresemba may have advantages related to its use in patients with reduced kidney function.


Q: How quickly does Cresemba start to work?

A: Pharmacokinetic data from regulatory documents shows that the active substance, isavuconazole, generally reaches its maximum concentration in the blood within 2 to 3 hours after the capsules are taken. However, the time required for a noticeable clinical response to the infection is determined by the patient's individual condition and the severity of the illness.


Q: Will taking Cresemba affect my driving ability?

A: Official safety data lists side effects such as dizziness and somnolence (drowsiness) as potential reactions, which may impact coordination. Individuals who experience these effects are cautioned against driving or operating machinery until they know how the medication affects them.


Q: How long do most people have to take Cresemba?

A: The necessary duration of treatment for an individual is based on their clinical response. Official documents state that continued treatment beyond six months requires careful consideration of the benefit-risk balance.


Q: Does Cresemba interact with birth control pills?

A: The active substance in Cresemba is a moderate inhibitor of a liver enzyme (CYP3A4) responsible for breaking down oral contraceptives. Clinical studies show that co-administration can increase the concentration of hormonal components like ethinyl estradiol and norethindrone in the body.


Q: Are there any genetic factors that affect how Cresemba works?

A: Yes, regulatory information specifies a genetic factor that affects eligibility. Cresemba is strictly contraindicated in patients with Familial Short QT Syndrome, which is an inherited problem affecting the electrical system of the heart.


Q: Is Cresemba considered a 'last resort' drug?

A: Regulatory summaries indicate that for the treatment of invasive mucormycosis, Cresemba is used when the existing first-line treatment, amphotericin B, is considered inappropriate for the patient. For invasive aspergillosis, it is studied as a comparable option to other antifungals.


Q: What is the risk of a drug interaction with Cresemba?

A: Cresemba has a defined profile of drug interactions because it is both a substrate and moderate inhibitor of the CYP3A4/5 liver enzymes, and a mild inhibitor of P-glycoprotein. Its use is strictly contraindicated with several strong enzyme inhibitors and inducers due to the potential for dangerous changes in the drug's levels.


Q: What is the likelihood of Cresemba failing to treat the infection?

A: Clinical trials do not report general 'failure rates' but rather measured outcomes like all-cause mortality. For invasive aspergillosis, all-cause mortality at 42 days was observed to be 19% in the Cresemba treatment group. For invasive mucormycosis, the all-cause mortality was observed to be 43% at 84 days.


Q: What if I take too much Cresemba?

A: In the event of a suspected overdose, regulatory guidance for overdose specifies contacting emergency services or a poison control center for assistance. Symptoms that have been associated with taking too much of the drug include headache, dizziness, drowsiness, and numbness.


Q: Are there alternatives to Cresemba for my infection?

A: Regulatory documents mention other antifungals, such as voriconazole and amphotericin B, in the context of clinical trials and treatment justification for the approved infections. These drugs may be considered alternatives depending on the patient's condition and medical history.


Q: Can Cresemba cause changes in vision?

A: Official safety data lists decreased vision as a reported side effect, although it is typically less common. If vision changes or other eye-related symptoms are experienced, consultation with a healthcare provider is appropriate.

How should Cresemba be stored and disposed of?

How to Store and Dispose of Cresemba (Isavuconazonium Sulfate)

Official regulatory guidelines establish distinct storage rules for each formulation.


Storage Requirements

Formulation Required Temperature Handling Constraints
Oral Capsules Controlled Room Temperature (20 C to 25 C) Must be protected from moisture in the original blister packaging.
Powder for Injection (Vial) Refrigerated (2 C to 8 C) The diluted solution must not be frozen and has limited stability after preparation.

Stability and Disposal

The intravenous solution must be completed within 6 hours at room temperature or 24 hours if refrigerated. The medication must be kept out of the sight and reach of children and safety caps must be locked. Any unused or expired product, including portions of the prepared injection solution, must be safely discarded according to local guidelines.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

Available in countries:

Equivalent of Cresemba found in:

A-Z Index: